QOL Medical, LLC, and its CEO, Frederick E. Cooper, have agreed to pay $47 million to settle allegations that they provided kickbacks to healthcare providers to encourage the submission of fraudulent claims for their drug, Sucraid, the U.S. Attorney’s Office for the District of Massachusetts announced.
Sucraid is an FDA-approved drug used to treat Congenital Sucrase-Isomaltase Deficiency (CSID), a rare genetic disorder that causes digestive issues with sucrose. As part of the settlement, QOL Medical and Cooper admitted to providing free Carbon-13 breath test kits to healthcare providers starting in 2018. Providers were encouraged to use these kits on patients exhibiting common gastrointestinal symptoms, despite the test not being specifically designed to diagnose CSID. The tests often showed false positives for low sucrase activity, which could result from factors unrelated to the condition.
From 2018 to 2022, QOL Medical paid a laboratory to analyze the results of the tests and provide healthcare providers with information that included the patients’ names and ages. This information was then used to target providers whose patients had positive test results, with QOL’s sales team instructed to push prescriptions for Sucraid.
The allegations were initially brought under the False Claims Act by former QOL employees, also known as whistleblowers, who will receive $8 million as part of the settlement. Of the total $47 million settlement, $43.6 million will be directed to federal health care programs, and $3.4 million will be allocated to state Medicaid programs.
The U.S. Department of Health and Human Services, Office of Inspector General, emphasized the importance of safeguarding taxpayer-funded healthcare programs, with Special Agent in Charge Roberto Coviello stating, “Kickback arrangements can compromise medical decisions and threaten the integrity of the Medicare program. We are committed to protecting patients and thoroughly pursuing False Claims Act violations.”
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